An Introduction to cGxP and Validation for Engineers

دانلود کتاب An Introduction to cGxP and Validation for Engineers

This book provides an integrated introduction to cGxP and Validation, all under one cover. It will take the reader through the key principles in Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Equipment Qualification (Equipment Validation), Test Method Validation and Process Validation. An ideal read for any Engineer wishing to refresh existing knowledge or learn new skill for the Medical Device and Pharmaceutical Industries.Process Validation examines, the consistency and stability of a process that is subject to predetermined specifications and controlled conditions. Process Validation also seeks to provide some â€œassuranceâ€ that a process will behave in controlled manner over time. This is typically expressed statistically in terms or a confidence level. While a packaging process is different to a machining or printing process, each process will exhibit one or more factors that can influence the consistency of the equipment or system.Case studies on Process Validation are also included to add a Practical and industry-based application.It is hoped that these examples will help to reinforce the principles and methodologies outlined in the book.